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Offer: Head, Pharmacovigilance:

Job description:

FORMA Therapeutics

 

Head, Pharmacovigilance

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Job detail

Job Summary:

This position reports to the Head of Translational Medicine and will work in a collaborative, cross-functional project team environment. The prosperous candidate will bring proven leadership abilities skills and a strong background in pharmacovigilance including cancer therapeutics. This person will lead the pharmacovigilance function across a growing, portfolio of small molecule therapeutics. This candidate will work jointly with clinical sciences, project leadership abilities and regulatory and provide oversight of drug safety for all products in clinical development at FORMA Therapeutics Inc.


Requirements

Responsibilities


       »
  • •Creation and oversight of the Pharmacovigilance department, including hiring of staff, writing SOPs, and bringing clinical safety database(s) in-house, as well as transition of safety case management from multiple CROs to in-house staff

    •Responsible for ensuring PhV inspection readiness for FDA or other HA inspection activities

    •Presenter at Investigator Meetings

    •Content owner /author of significant sections of investigational and marketed product pharmacovigilance related documents (e.g. DSUR, PBRER).

    •Author and reviewer of applicable sections of protocols, Investigator Brochure, informed consents

    •Author of global risk management plans, aggregate reports and benefit/risk assessments

    •Lead Safety Review Meetings for each company product

    •leadership abilities of EU Pharmacovigilance requirements including QPPV oversight, EVMPD, PSMF

    •continuing review of data listings, including adverse events (serious and non-serious), concomitant medications, lab values, and EKG/QTc data, as applicable

    •Participation on cross-functional Program Teams, Study Teams, and Site Teleconferences

    •Participation in creation and/or authorship of safety data exchange agreements with collaborative partners and Sponsor-Investigators

    •Review of serious adverse event reports and creation of Analysis of Prior Similar Events for expedited reports in compliance with local regulatory requirements

    •Review of concomitant medication WHO drug coding and adverse event/medical history MedDRA coding

    Minimum Basic Qualifications, skills, competencies and practice:

    •At least 10 years oncology practice with pharmaceutical/biotech PV (safety signal detection, data mining techniques, pharmacovigilance databases)

    •Post-graduate degree in a significant discipline

    •Additional practice in non-oncology therapeutic areas (Immunology or hematology) is a plus

    •A creative problem solver with the proven capability to work independently and collaboratively in a fast-paced, results-oriented and dynamic environment

    •Excellent interpersonal skills and a demonstrated capability to work well within team structure is essential

    •Demonstrated practice with strategic partners, CROs and vendors

    •Strong written and verbal communication skills.

About FORMA

FORMA Therapeutics’ scientists are passionate about discovering and developing medicines that will make a difference in oncology and other genetically driven therapeutic areas. The Company’s drug discovery engine drives screening and structure-located approaches across broad families of targets involved in tumor metabolism, epigenetics, protein homeostasis and protein-protein interactions. Leveraging a world class network of academic investigators, clinical experts and corporate partners, FORMA combines deep biological insight and chemistry skills to rapidly create high quality, innovative drug candidates.

FORMA is headquartered in Watertown, MA near the epicenter of the Cambridge Life Sciences cluster, with operations in both Watertown, MA and Branford, CT. www.formatherapeutics.com

Please send resumes to careers@formatherapeutics.com and reference job code #10110 in the subject line.

No phone calls please. Resumes from third party vendors will not be accepted.



Job Information

       »
  • : Watertown, Massachusetts, United States

  •    »
  • : 44853606

  •    »
  • : November 9, 2018

  •    »
  • : Head, Pharmacovigilance

  •    »
  • : FORMA Therapeutics

  •    »
  • : Management

  •    »
  • : No

  •    »
  • : Full-Time

  •    »
  • : Ph.D.

  •    »
  • : Over 10 Years


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    Job Category: Other [ View All Other Jobs ]
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    Salary: Unspecified
    Degree: Unspecified
    Experience (year): Unspecified
    Job Location: Watertown, Massachusetts
    Company Type Employer
    Post Date: 11/09/2018 / Viewed 11 times
    Contact Information
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    Contact Email: careers@formatherapeutics.com


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